Her 2 Testing in Indian Patients With Gastric Cancer
"An Observational Study to Determine the Incidence of of Her 2 Positivity in 100 Consecutive Gastric Cancers"
Gastric cancer remains a major health issue and a leading cause of cancer death worldwide, although the prevalence and mortality of the disease have gradually decreased. The investigators have very few options for patients with advanced disease.
The trastuzumab for Gastric Cancer (ToGA) trial, a pivotal randomized clinical trial of patients with HER-2 positive advanced, mostly metastatic, gastric cancer, proved the efficacy of trastuzumab (anti-Her 2 therapy) in combination with chemotherapy. The median overall survival was significantly prolonged in the trastuzumab-containing arm (13.8 vs. 11.1 months; HR 0.74; p=0.0046) without unexpected toxicity including cardiac events. The survival benefit was most pronounced in the subgroup of high HER-2/neu protein overexpression (median overall survival of 16 months). Only 20% of the patients screened and subsequently enrolled for this study were found to be HER2-positive when utilizing both immunohistochemistry and FISH. Her2 testing is recommended for all patients with advanced gastric cancers and type III oesophageal adenocarcinomas.
Data on Indian patients is lacking. Hence, the investigators plan to test for Her 2 in 100 patients with IHC and FISH in 2+ and 3+ patients.
研究概览
地位
条件
详细说明
Study Objective/ Aims Aim: - Rate of Her 2 positivity in 100 consecutive gastric cancer patients Primary Objective
Test for Her 2 in 100 consecutive gastric cancer patients Immuno-histochemistry will be done in all patients. Patients with 2 and 3+ IHC will also have FISH done.
Study Design& Methodology
Patients will have the Her2 tested in 100 consecutive gastric cancer samples by immunohistochemistry and patients with 2+ and 3+ result will also have FISH done. This will not affect patient management
- Overview of Data collection Dr.Bhawna Sirohi the principal investigators will maintain and supervise data collection and maintaining records. The patient will be de-identified.
- Selection of Study Population
Inclusion Criteria:
100 consecutive patients with gastric cancer who have a pathology specimen at TMH
Exclusion Criteria:
If histopathology blocks were not available
5) Sample size 100 to be enrolled. Patient consent waiver applied for as this does not affect patient care 6) Statistical Analysis It is an Observational study so Results will be given as %age of total population.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Maharashtra
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Mumbai、Maharashtra、印度、400012
- Tata Memorial Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- 100 consecutive patients with gastric cancer who have a pathology specimen at TMH
Exclusion Criteria:
- If histopathology blocks were not available
学习计划
研究是如何设计的？
设计细节
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Incidence of Her2 testing in Gastric cancer
大体时间：6 month
|
Immuno-histochemistry will be done in all patients.
Patients with 2 and 3+ IHC will also have FISH done.
|
6 month
|
合作者和调查者
调查人员
- 首席研究员：Dr Bhawna Sirohi, MBBS DCH、Consulting Medical Oncologist
- 首席研究员：Shailesh Shrikhande, MS、Professor of Surgical GI and HPB surgery
- 首席研究员：Mukta Ramadwar, MD、Consultant Pathologist
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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